A pivotal clinical study in the U.S. on the Tendyne Transcatheter Mitral Valve Replacement (TMVR) system for treating mitral regurgitation has been commenced by Abbott.
The U.S. Food and Drug Administration expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects. Specifically, the agency approved the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff to include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world.
A new study has found that a pioneering device to repair heart valves is safe and effective, and can reduce the invasiveness and side effects of conventional mitral valve surgery.
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